BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SESTAMIBI-R-

    MDR report key: 2240771 · Received September 2, 2011

    Report

    Report Number
    MW5022124
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 2, 2011
    Manufacturer
    PHARMALOGIC
    Product Code
    KTA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    (B)(6) REPORTED ON (B)(6) 2011 THAT THEY WERE AWARE OF A ALTERED BIODISTRIBUTION ISSUE WITH SESTAMIBI-R- DUE TO A GENERATOR MALFUNCTION. LOT AFFECTED WAS 1134. PRODUCT PASSED THE COMPANY'S QI AND ASSAYED FOR THE CORRECT AMOUNTS OF SESTAMIBI-R-. HOWEVER, AFFECTED PT'S HEART WAS UNABLE TO BE VISUALIZED ON NUCLEAR SCAN DURING CARDIAC STRESS TESTING DUE TO THE INCREASED UPTAKE BY OF THE RADIOISOTOPE BY THE STOMACH AND BOWEL. PATIENT DID NOT SUFFER ANY HARM, BUT IS INCONVENIENCED BY HAVING THE TEST REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SESTAMIBI-R- SESTAMIBI-R- KTA PHARMALOGIC 1134

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other